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FDA 510(k)

Xenocor Xenoscope Laparoscopic System

K-Number: K161838 · 2016-09-26

ApplicantXenocor, Inc.
Decision Date2016-09-26
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Xenocor Xenoscope Laparoscopic System is the device name listed in this FDA 510(k) record. The listed applicant is Xenocor, Inc.. It received FDA 510(k) clearance on 2016-09-26 under 510(k) number K161838. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Xenocor Xenoscope Laparoscopic System?

Xenocor Xenoscope Laparoscopic System is a medical device that received FDA 510(k) clearance on 2016-09-26. The listed applicant is Xenocor, Inc.. The 510(k) number is K161838.

When did Xenocor Xenoscope Laparoscopic System receive FDA 510(k) clearance?

Xenocor Xenoscope Laparoscopic System received FDA 510(k) clearance on 2016-09-26, under 510(k) number K161838.

Who is the listed applicant for Xenocor Xenoscope Laparoscopic System?

The FDA 510(k) record lists Xenocor, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Xenocor Xenoscope Laparoscopic System?

The FDA product code for Xenocor Xenoscope Laparoscopic System is GCJ.

Other records listing Xenocor, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260177Saberscope™ Laparoscope (SAS-A-536L); Xenocor® Video Processing Unit (VPUX-1)K220872Saberscope5 LaparoscopeK193315Xenocor Articulating Xenoscope LaparoscopeK171344Xenocor Xenoscope Laparoscopic System

Related Devices (Code: GCJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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